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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130021 S010/ PAS001 |
| Study Name |
Continued f/u of the premarket cohort
|
| Device Name |
MEDTRONIC COREVALVE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of all living subjects who were enrolled under the IDE in Registry 6: TAV-in-SAV. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
|
| Study Population |
All living subjects who were enrolled in the ¿TAV-in-SAV¿ Registry
|
| Sample Size |
All living subjects.
|
| Key Study Endpoints |
The safety and effectiveness endpoints include all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), change in functional status and quality of life, conduction disturbance requiring permanent pacemaker implantation, echocardiographic assessment, and valve dysfunction.
|
| Follow-up Visits and Length of Follow-up |
5 years
All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
232
|
| Actual Number of Sites Enrolled |
38
|
| Patient Follow-up Rate |
The follow-up rate through 5 years was approximately 88%
|
| Final Safety Findings |
The Kaplan-Meier rates of CEC-adjudicated safety outcomes at 5 years are summarized as follows:
All-cause mortality or major stroke: 47.2%
All-cause mortality: 46.8% (29.8% cardiovascular mortality)
Valve-related death: 4.7%
All stroke: 9.8% (6.7% major stroke)
Aortic valve rehospitalization: 31%
Reintervention: 5.9%
Major adverse cardiovascular and cerebrovascular event (MACCE): 51.7%
Bleeding: 34.7%
New permanent pacemaker: 24%
|
| Final Effect Findings |
Key effectiveness outcomes are summarized as follows, in subjects who were evaluated for each outcome measure at the 5-year visit:
NYHA Classification: There was improvement in NYHA classification from baseline to 5-years. The mean change compared to baseline at 5 years was -1.4 +/- 0.9 (n=78).
KCCQ: Improvement was observed in both overall and clinical summary scores through five years. The change in KCCQ overall summary score at 5 years compared to baseline was 27.6 +- 23.3 (n=80).
Valve Performance Outcomes:
Mean gradient decreased from 37.84 +/- 18.03 at baseline to 15.62 +/- 8.79 at 30 days. At 5-years, the overall mean gradient was 14.12 + 9.81 mmHg (n=72).
Mean effective orifice area (EOA) increased from 1.02 +/- 0.61 cm2 at baseline to 1.45 +/- 0.63 cm2 at 30 days. At 5 years, the EOA was 1.57 0.70 cm2 (n=62).
At 5 years, 93.2% of subjects with available echocardiographic data (n=74) had mild or less total aortic regurgitation (AR).
|
| Study Strengths & Weaknesses |
This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the Medtronic CoreValve System in patients with symptomatic severe aortic stenosis with predicted operative mortality or serious, irreversible morbidity risk of greater than or equal to 50% at 30 days who received a transcatheter implantation of the CoreValve System in a failed surgical prosthetic aortic valve (TAV-in-SAV). Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvements shown for key effectiveness endpoints from baseline to 5 years. However, Echocardiography Corelab and Quality of Life compliance rates at 5 years are low (53-70%). The incomplete data may impact the ability to interpret and draw conclusions from the results.
|
| Recommendations for Labeling Changes |
The labeling is recommended to be updated to reflect the 5 year findings of the study and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.
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